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Principle Medical Writer: MedFocus
    PRINCIPLE MEDICAL WRITER
COMPANY INFO: MedFocus offers clinical research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries. We specialize in the nationwide recruitment of clinical trials personnel. Our client is committed to earning the trust of doctors, patients and customers every day and is seeking to add a Principle Medical Writer to their team in Kenilworth, NJ. RESPONSIBILITIES: • Will be responsible for the preparation of clinical documents for worldwide submissions to regulatory authorities and for leading medical writing teams assembled to support large projects. • Will support Managers within Medical Communications by providing technical guidance to junior members of the department. • Independent preparation of clinical study reports, integrated clinical summaries, overviews, and other regulatory documents on investigational drugs in various stages of clinical development. • Lead medical writing teams assembled for large projects, e.g. submissions; coordinate and direct work of internal or external medical writers assigned to the writing team. • In conjunction with Director and MedCom Managers, will coordinate resource allocation and identify projects that exceed capacity of internal Medical Writing staff. • Will serve as liaison between outside writing sources and will review documents prepared by those outside resources. • Will serve as department's representative for assigned therapy team/working groups; and will participate in determining submission-level timelines. • Will review, update and communicate the operational and functional procedures utilized by the department with regard to document creation, review, quality control and publishing/archiving. Will also serve as a technical expert for the department and represent the department in cross-functional decision making teams and committees. QUALIFICATIONS: • An advanced degree in Life Sciences - PhD or PharmD preferred. • 5-10 years in Pharmaceutical Research & Development, with at least 3 of those years in Medical Writing. MedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable.
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